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Effects of Dronabinol (Oral THC) on Cannabis Use

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01394185
First received: July 12, 2011
Last updated: August 2, 2017
Last verified: August 2017
  Purpose
Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.

Condition Intervention Phase
Marijuana Smoking Drug: Dronabinol 120mg/day Drug: Placebo Drug: Dronabinol 240mg/day Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Dronabinol (Oral THC) on Cannabis Use

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Marijuana Self-administration - Progressive Ratio [ Time Frame: 12-day Dronabinol maintenance period ]
    Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint

  • Marijuana Self-administration - Drug Vs Money Choice [ Time Frame: 12-day Dronabinol maintenance period ]
    Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint


Enrollment: 25
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Dose Dronabinol, High Dose Dronabinol, and placebo
Participants were administered dronabinol (0 mg/day, 120mg/day and 240mg/day) for 12 days each in a random order
Drug: Dronabinol 120mg/day
Participants receive 40mg dronabinol 3 times daily
Other Names:
  • Marinol
  • THC
Drug: Placebo
Participants receive placebo
Drug: Dronabinol 240mg/day
Participants receive 80mg dronabinol 3 times daily
Other Names:
  • Marinol
  • THC

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current use of marijuana
  • Able to give informed consent

Exclusion Criteria:

  • Daily use of psychoactive medication
  • Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol
  • Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months
  • Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder
  • Uncontrolled or unstable cardiovascular disease
  • Allergy to sesame oil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394185

Locations
United States, Maryland
Johns Hopkins University (Bayview Campus)
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ryan Vandrey, Ph.D. Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01394185     History of Changes
Other Study ID Numbers: NA_00041251
R01DA025044 ( U.S. NIH Grant/Contract )
Study First Received: July 12, 2011
Results First Received: April 18, 2017
Last Updated: August 2, 2017

Keywords provided by Johns Hopkins University:
marijuana
dronabinol
pharmacotherapy

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 19, 2017